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DEVELOPMENT AND LICENSE AGREEMENT

Development Agreement

DEVELOPMENT AND LICENSE AGREEMENT | Document Parties: IMMUNOGEN INC |  Centocor, Inc You are currently viewing:
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IMMUNOGEN INC | Centocor, Inc

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Title: DEVELOPMENT AND LICENSE AGREEMENT
Governing Law: Massachusetts     Date: 2/9/2005
Industry: Biotechnology and Drugs     Law Firm: Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.     Sector: Healthcare

DEVELOPMENT AND LICENSE AGREEMENT, Parties: immunogen inc ,  centocor  inc
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Exhibit 10.2

 

DEVELOPMENT AND LICENSE AGREEMENT

 

This Development and License Agreement (this “Agreement”) is made effective as of December 23, 2004 (the “Effective Date”) by and between Centocor, Inc., a wholly owned subsidiary of Johnson & Johnson, with its principal place of business at 200 Great Valley Parkway, Malvern, Pennsylvania 19355 (“Centocor”), and ImmunoGen, Inc., a Massachusetts corporation with its principal place of business at 128 Sidney Street, Cambridge, Massachusetts 02139 (“ImmunoGen”).  Centocor and ImmunoGen are sometimes each hereinafter referred to individually as a “Party” and collectively as the “Parties”.

 

WHEREAS, Centocor is the owner of or otherwise controls certain rights in proprietary technology and know-how relating to certain [*******************] Antibodies (as defined below); and

 

WHEREAS, ImmunoGen is the owner of or otherwise controls certain rights in proprietary technology and know-how relating to or otherwise useful in the conjugation of maytansine derivatives to binding proteins; and

 

WHEREAS, pursuant to the terms and conditions set forth herein, Centocor desires to obtain from ImmunoGen, and ImmunoGen desires to grant to Centocor, a license under certain of ImmunoGen’s Technology and/or Patent Rights to develop and commercialize one or more Licensed Products (as defined below).

 

NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Parties hereby agree as follows:

 

1.                                       DEFINITIONS

 

Whenever used in the Agreement with an initial capital letter, the terms defined in this Section 1 shall have the meanings specified.

 

1.1.                             Adverse Event ” shall mean any untoward medical occurrence in a patient or subject who is administered a Licensed Product, whether or not considered related to the Licensed Product including, without limitation, any undesirable sign (including abnormal

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 



 

laboratory findings of clinical concern), symptom or disease temporally associated with the use of such Licensed Product.

 

1.2.                             Affiliate ” shall mean any corporation, firm, limited liability company, partnership or other entity which directly or indirectly controls or is controlled by or is under common control with a Party to this Agreement.  For purposes of this Section 1.2, “control” means ownership, directly or indirectly through one or more Affiliates, of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or fifty percent (50%) or more of the equity interests in the case of any other type of legal entity, or status as a general partner in the case of any partnership, or any other arrangement whereby a Party controls or has the right to control the Board of Directors or equivalent governing body or management of a corporation or other entity.

 

1.3.                             Agreement ” shall mean this Development and License Agreement between the Parties, dated as of the Effective Date, including any exhibits, schedules or other attachments hereto and incorporated herein, as any of the foregoing may be validly amended from time to time.  In the event of any inconsistency between the terms of this Agreement and the terms of any exhibits, schedules or other attachments incorporated herein, unless the Parties expressly agree otherwise in writing the terms of this Agreement shall govern.

 

1.4.                             [***************************] shall mean any [**************************] consisting of an [**************] in [*********************************].

 

1.5.                             [***************************] -MAY Conjugate ” shall mean any conjugate of an [********************************] Antibody with a MAY Compound.

 

1.6.                             Ansamitocins ” shall mean precursor(s) of MAY Compound produced by microbial fermentation, such as Ansamitocin P0, P1, P2, P3, P3’, P4, and P4’.

 

1.7.                             [***************************] Antibody ” shall mean any Antibody (including [********] that is Controlled by Centocor and that targets [*************************].

 

1.8.                             Antibody ” shall mean a composition comprising a whole antibody or fragment

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

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thereof (whether polyclonal or monoclonal, human, humanized, chimeric or murine, or derived from another relevant species, multiple or single chain, recombinant, transgenic animal derived or naturally occurring, and any constructs thereof) or having been derived from nucleotide sequences encoding, or amino acid sequences of, such an antibody or fragment.

 

1.9.                             Centocor Background Technology ” means any Technology used by Centocor or provided by Centocor for use, in the Research Program that is useful in the Field and that is (a) Controlled by Centocor as of the Effective Date or (b) Controlled by Centocor and developed or conceived by employees of, or consultants to, Centocor on and after the Effective Date in the conduct of activities outside the Research Program and without the use of any Licensed Technology, Licensed Patent Rights or Joint Program Technology.   Any Centocor Background Technology Controlled by Centocor as of the Effective Date is, or that becomes Controlled by Centocor on and after the Effective Date shall be, described in Schedule C attached hereto and incorporated herein by reference.

 

1.10.                      Centocor Patent Rights ” shall mean all Patent Rights with respect to Centocor Background Technology.

 

1.11.                      Centocor Program Technology ” shall mean any Program Technology made solely by employees of, or others obligated to assign inventions to, Centocor or any Affiliate of Centocor.

 

1.12.                      Clinical Materials ” shall mean any MAY Compound or Licensed Product supplied by ImmunoGen to Centocor pursuant to Section 4.3 and/or the terms of a Supply Agreement for use in human clinical testing.

 

1.13.                      Collaboration Committee ” shall mean the committee with representatives of each Party established as set forth in Section 3.4.

 

1.14.                      [***************************************] shall mean a [*****] of [************] in [********************] to [***************] of [********] of [****************] to [***********************************] and [********] launch of a product incorporating MAY Compound.

 

1.15.                      Commercialization ” or “ Commercialize ” shall mean any and all activities

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

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directed to pre-launch and launch of Licensed Products, including marketing, promoting, distributing, offering for sale and selling such Licensed Product, importing Licensed Products for sale, manufacturing for commercial sale (except for scale-up activities, which shall be Development activities) and securing reimbursement for sales. When used as a verb, “Commercialize” shall mean to engage in Commercialization.

 

1.16.                      Confidential Information ” shall mean, with respect to a Party (the “receiving Party”), all information which is disclosed by the other Party (the “disclosing Party”) to the receiving Party hereunder or to any of its employees, consultants, Affiliates, licensees or sublicensees, except to the extent that the receiving Party can demonstrate by written record or other suitable physical evidence that such information, (a) as of the date of disclosure is demonstrably known to the receiving Party or its Affiliates other than by virtue of a prior confidential disclosure to such Party or its Affiliates; (b) as of the date of disclosure is in, or subsequently enters, the public domain, through no fault or omission of the receiving Party; (c) is obtained from a Third Party having a lawful right to make such disclosure free from any obligation of confidentiality to the disclosing Party; or (d) is independently developed by or for the receiving Party without reference to or reliance upon any Confidential Information of the Disclosing Party.  For purposes of clarity, (a) any technical or financial information of a disclosing Party disclosed at any meeting of the Collaboration Committee, or disclosed through an audit report shall constitute Confidential Information of such disclosing Party, (b) the terms of this Agreement, to the extent not disclosed in a public filing (or press release permitted under Section 6 of this Agreement, shall constitute Confidential Information of each Party unless otherwise specified, (c) all know-how and trade secrets disclosed by ImmunoGen to Centocor in connection with the licenses set forth in Section 2.1 of this Agreement shall constitute Confidential Information of ImmunoGen, and (d) all know-how and trade secrets disclosed by Centocor to ImmunoGen in connection with the license set forth in Section 2 of this Agreement shall constitute Confidential Information of Centocor.

 

1.17.                      Consumer Price Index or “CPI ” shall mean the CPI for All Urban Consumers published from time to time by the Bureau of Labor Statistics of the United States Department of

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

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Labor.

 

1.18.                      Contract Year ” shall mean the period beginning on the Effective Date and ending on December 31, 2005 and each succeeding twelve (12) month period thereafter during the Term.

 

1.19.                      Control ” or “ Controlled ” shall mean, with respect to any Patent Rights, Technology or Proprietary Materials (including, without limitation, any MAY Compound, [*********************************] Antibody or other proprietary biologic material covered under this Agreement), the possession by a Party of the ability to grant a license or sublicense of such Patent Rights or Technology and the rights thereto or to supply such Proprietary Materials as provided for in this Agreement without violating the terms of any arrangement or agreement between such Party or its Affiliates and any Third Party.

 

1.20.                      Cost ” shall mean, with respect to any Preclinical Materials or Clinical Materials manufactured by ImmunoGen, ImmunoGen’s fully-burdened costs (including the costs associated with product testing and release activities) of producing and packaging such Preclinical or Clinical Materials, including the sum of the following components:  (a) direct costs, including (1) materials directly used in producing and packaging such Preclinical Materials or Clinical Materials and (2) with respect to any Preclinical Materials or Clinical Materials obtained by ImmunoGen from a Third Party and supplied to Centocor without modification, the amount paid by ImmunoGen to such Third Party for the same; (b) manufacturing overhead costs attributable to the cost of goods under the foregoing clause (a) (1), including manufacturing and quality labor and manufacturing and quality supervisory services, operating and administrative costs of the manufacturing and quality departments and occupancy costs which are allocable to company departments based on space occupied or headcount, or another activity-based method; (c) any other reasonable and customary out-of-pocket costs borne by ImmunoGen for the testing, transport, customs clearance, duty, insurance and/or storage of such Preclinical Materials or Clinical Materials; and (d) ImmunoGen’s general and administrative costs, including purchasing, human resources, payroll, information system and accounting, which are directly attributable or reasonably allocable to company departments

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

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based on space occupied or headcount or another activity-based method.  In no event shall Manufacturing Costs include costs associated with idle capacity.  Manufacturing overhead costs under the foregoing clause (b) and general and administrative costs under the foregoing clause (d) are allocable to each batch of Preclinical Material and/or Clinical Material produced based upon the [******] of [******], or any portion of a [****], that a Manufacturing [*****] is [**********] for the [**********] (including [*****************] and [*******]) if Preclinical Materials or Clinical Materials, as the use may be, at ImmunoGen’s facilities.  Notwithstanding the foregoing, Cost shall not include the cost of purchasing any Dedicated Equipment pursuant to Section 4.4 of this Agreement.

 

1.21.                      Dedicated Equipment ” shall mean any equipment, instrument or machinery used by ImmunoGen exclusively in the manufacturing of Preclinical Materials or Clinical Materials.

 

1.22.                      Development ” and “ Develop ” shall mean, with respect to any Licensed Product, all activities with respect to such Licensed Product relating to research and development in connection with seeking, obtaining and/or maintaining any Regulatory Approval for such Licensed Product in the Field in the Territory, including without limitation, all pre-clinical research and development activities, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, development-stage manufacturing, quality assurance/quality control development and performance, all activities relating to developing the ability to manufacture any Licensed Product or any component thereof (including, without limitation, process development work), and all other activities relating to seeking, obtaining and/or maintaining any Regulatory Approvals from the FDA and/or any Foreign Regulatory Authority.

 

1.23.                      Drug Approval Application ” shall mean any application for Regulatory Approval (including pricing and reimbursement approvals) required prior to any commercial sale or use of a Licensed Product in any country or jurisdiction in the Territory, including, without limitation, (a) any NDA or other regulatory application filed with the FDA prior to any commercial sale or use of a Licensed Product in the United States, and (b) any MAA or other

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

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equivalent regulatory application filed with any Foreign Regulatory Authority for Regulatory Approval (including pricing and reimbursement approvals) required prior to any commercial sale or use of a Licensed Product in any other country or jurisdiction in the Territory.

 

1.24.                      Effective Date ” shall mean the date first written above in the introductory paragraph to this Agreement.

 

1.25.                      FDA ” shall mean the United States Food and Drug Administration and any successor agency or authority thereto.

 

1.26.                      Field ” shall mean all human therapeutic uses.

 

1.27.                      First Commercial Sale ” shall mean the date of the first commercial transfer or disposition for value to a Third Party of a Licensed Product by or on behalf of Centocor or any Affiliate or Sublicensee of Centocor.

 

1.28.                      Foreign Regulatory Authority ” shall mean any applicable supranational, national, federal, state or local regulatory agency, department, bureau or other governmental entity of any country or jurisdiction in the Territory (other than the FDA in the United States), including, without limitation, the Europeon Medicines Agency, having responsibility in such country or jurisdiction for any Regulatory Approvals of any kind in such country or jurisdiction, and any successor agency or authority thereto.

 

1.29.                      Full Time Equivalent ” or “ FTE ” a full time person dedicated to the Research Program, or in the case of less than a full-time dedicated person, a full-time, equivalent person year, based on a total of at least [************] or [*******************] per year of work, on or directly related to the Research Program, and which is carried out by employees, contractors or agents of ImmunoGen having the appropriate scientific expertise to conduct such activities.

 

1.30.                      FTE Cost ” shall mean, for any period during the Term of this Agreement, the FTE Rate multiplied by the number of FTEs expended over such period.

 

1.31.                      FTE Rate ” shall mean, for the [*****] Contract Year commencing on the Effective Date, [*************]; and, for each Contract Year thereafter, the result obtained by multiplying [*************] by the sum of (1+CPI) where CPI is a fraction, the numerator of

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

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which is the difference between the Consumer Price Index as of the last month of the immediately preceding Contract Year and the Consumer Price Index as of the month immediately preceding the Effective Date and the denominator of which is the Consumer Price Index as of the month immediately preceding the Effective Date.

 

1.32.                      GMPs ” shall mean all good manufacturing practices under Title 21 of the United States Code of Federal Regulations, as amended from time to time.

 

1.33.                      ImmunoGen Materials ” shall mean any Proprietary Materials Controlled by ImmunoGen and used by ImmunoGen, or provided by ImmunoGen for use, in the Research Program.  ImmunoGen Materials shall include, without limitation, any MAY Compound.

 

1.34.                      ImmunoGen Program Technology ” shall mean any Program Technology made solely by employees of, or agents or others obligated to assign inventions to, ImmunoGen or an Affiliate of ImmunoGen.

 

1.35.                      Improvement ” shall mean any enhancement, improvement or modification to the Licensed Technology or the Licensed Patent Rights which is conceived or reduced to practice by either Party in the conduct of the Research Program and/or in connection with the development of any Licensed Product.

 

1.36.                      IND ” shall mean an investigational new drug application (as defined in Title 21 of the United States Code of Federal Regulations, as amended from time to time) filed or to be filed with the FDA with regard to any Licensed Product.

 

1.37.                      Indemnitees ” and “ Indemnifying Party ” shall have the meanings set forth in Section 9.

 

1.38.                      Joint Program Technology ” shall mean any Program Technology made jointly by one or more employees of or agents to, or other persons obligated to assign inventions to, ImmunoGen or an ImmunoGen Affiliate, and by one or more employees of or agents to, or other persons obligated to assign inventions to, Centocor or a Centocor Affiliate.

 

1.39.                      Licensed Patent Rights ” shall mean any Patent Rights in the Field which are Controlled by ImmunoGen as of the Effective Date or become Controlled by ImmunoGen during the Term (including ImmunoGen’s interest in any ImmunoGen Program Technology and Joint

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

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Program Technology covered by Patent Rights that are Controlled by ImmunoGen), to the extent necessary to Develop, have Developed, make, have made, use, sell, have sold, import or export any Licensed Product in the Field in the Territory.  Licensed Patent Rights as of the Effective Date are set forth in Schedule A attached hereto and incorporated herein by reference.

 

1.40.                      Licensed Product ” shall mean any product that incorporates, is comprised of, or is otherwise derived from, an [***************]- MAY Conjugate.

 

1.41.                      Licensed Technology ” shall mean any Technology in the Field which is Controlled by ImmunoGen as of the Effective Date or becomes Controlled by ImmunoGen during the Term (including ImmunoGen’s interest in any ImmunoGen Program Technology and Joint Program Technology), which is necessary or useful to Develop, have Developed, make, have made, use, sell, have sold, import or export any Licensed Product in the Field in the Territory.

 

1.42.                      MAA ” shall mean an application filed with the relevant Foreign Regulatory Authorities in Europe seeking Regulatory Approval to market and sell any Licensed Product in Europe or any country or territory therein for a particular indication within the Field.

 

1.43.                      [*****************************] shall mean the [*********] of (a) an [*****] (such [*****] to [*****] the [****] under (b) below) of a [****************] by [******] that [*******************] to [******************] that the [*******************] is [*******] of using [***********************************] to [******************** ****************] to [**********************] in terms of [************************] and [***************] for [*********] to be used in (i) [***************************] involving [**************] and (ii) [******************************] of a [****************], and (b) the [*********] by [*********] or [******] and [************ *************] of a [***************] that [*********************************] is [***********] with the [*****] of [*******] as described under (a) above.  For the avoidance of doubt, if [*******] chooses [***] to [*******] the [*****] under (a) above [*****] to the [********] of the [****************] referenced under (b) above, the [****************** *************] will be [**************] and

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

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[*********] upon the [*********] of only (b) above.

 

1.44.                      MAY Compound ” shall mean any and all maytansinoid compounds and any and all derivatives of any such maytansinoid compounds, to the extent, in any case, Controlled by ImmunoGen, including without limitation, (a) N 2’ -deacetyl-N 2’ -(3-mercapto-1-oxopropyl)-maytansine (CAS No. 139504-50-0) (commonly referred to as DM1); (b) N 2’ -deacetyl-N 2 -(4-mercapto-1-oxopentyl)-maytansine (commonly referred as DM3); and (c) N 2’ -deacetyl-N 2 -(4-mercapto-4-methyl-1-oxopentyl)-maytansine (commonly referred as DM4).

 

1.45.                      MTA shall mean that certain Material Transfer and Evaluation Agreement between Centocor and ImmunoGen dated [***************], as amended on [********************] and [********************].

 

1.46.                      NDA ” shall mean a new drug application (as defined in Title 21 of the United States Code of Federal Regulations, as amended from time to time) filed with the FDA seeking Regulatory Approval to market and sell any Licensed Product in the United States for a particular indication within the Field.

 

1.47.                      Net Sales ” shall mean, as to each calendar quarter during the Term, the gross invoiced sales prices charged for all Licensed Products sold by Centocor or its Sublicensees to Third Parties throughout the Territory during such calendar quarter, less the following amounts incurred or paid by Centocor or its Sublicensees during such calendar quarter with respect to sales of Licensed Products regardless of the calendar quarter in which such sales were made:

 

(a)                                    (i) trade, cash and quantity discounts actually allowed or taken, including discounts to governmental or managed care organizations; (ii) rebates actually paid or credited, including government rebates such as Medicaid chargebacks or rebates; (iii) retroactive price reductions or allowances actually allowed or granted from the billed amount; and (iv) commercially reasonably promotional allowances actually granted to customers as reflected on the same invoice as for the sale of Licensed Product

 

(b)                                   credits or allowances actually given or made for rejection of or return of, previously sold Licensed Products;

 

(c)                                    any charges for insurance, freight, and other transportation costs directly

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

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related to the delivery of Licensed Product to the extent included in the gross invoiced sales price;

 

(d)                                   any tax, tariff, duty or governmental charge levied on the sales, transfer, transportation or delivery of a Licensed Product (including any tax such as a value added or similar tax or government charge) borne by the seller thereof, other than franchise or income tax of any kind whatsoever; and

 

(e)                                    any import or export duties or their equivalent borne by the seller.

 

“Net Sales” shall not include sales or transfers between Centocor and its Affiliates, unless the Licensed Product is consumed by the Affiliates.

 

1.48.                      Patent Rights ” shall mean the rights and interests in and to any and all issued patents and pending patent applications (including inventor’s certificates and utility models) in any country or jurisdiction in the Territory, including any and all provisionals, non-provisionals, substitutions, continuations, continuations-in-part, divisionals and other continuing applications, supplementary protection certificates, renewals, and all letters patent on any of the foregoing, and any and all reissues, reexaminations, extensions, confirmations, registrations and patents of addition on any of the foregoing.

 

1.49.                      Phase II Clinical Trial ” shall mean, as to a particular Licensed Product for a particular indication, a controlled and lawful study in humans of the safety, dose ranging and efficacy of such Licensed Product for such indication, which is prospectively designed to generate sufficient data (if successful) to commence a Pivotal Clinical Trial of such Licensed Product for such indication.

 

1.50.                      Pivotal Clinical Trial ” shall mean, as to a particular Licensed Product for a particular indication, a controlled and lawful study in humans of the safety and efficacy of such Licensed Product for such indication, which is prospectively designed to demonstrate statistically whether such Licensed Product is safe and effective for use in such indication in a manner sufficient to file an NDA to obtain Regulatory Approval to market and sell that Licensed Product in the United States or in any other country in the Territory for the indication under investigation in such study.

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

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1.51.                      Preclinical Materials ” shall mean any MAY Compound and/or [***************************]-MAY Conjugate supplied by ImmunoGen to Centocor in accordance with Section 4.2 for the purpose of conducting research activities and/or preclinical testing under the Research Program with respect to a Licensed Product.

 

1.52.                      Program Technology shall mean any Technology, whether or not patentable, conceived or reduced to practice in the conduct of the Research Program, or, during the manufacture of Preclinical Material or Clinical Material in accordance with Section 4 of this Agreement.

 

1.53.                      Proprietary Materials ” shall mean any tangible chemical, biological or physical research materials that are furnished by or on behalf of one Party to the other Party in connection with this Agreement, regardless of whether such materials are specifically designated as proprietary by the transferring Party.

 

1.54.                      Regulatory Approval ” shall mean any and all approvals (including pricing and reimbursement approvals), product and establishment licenses, registrations or authorizations of any kind of the FDA or any Foreign Regulatory Authority necessary for the development, pre-clinical and/or human clinical testing, manufacture, quality testing, supply, use, storage, importation, export, transport, marketing and sale of a Licensed Product (or any component thereof) for use in the Field in any country or other jurisdiction in the Territory.  “Regulatory Approval” shall include, without limitation, any NDA, MAA or any other Drug Approval Application.

 

1.55.                      Regulatory Authority shall mean the FDA and/or a Foreign Regulatory Authority.

 

1.56.                      Research Budget shall mean the budget for the Research Plan as agreed to by the parties.

 

1.57.                      Research Plan ” shall mean the written plan describing the research activities to be carried out by each Party pursuant to this Agreement attached hereto as Appendix 3.1 .

 

1.58.                      Research Program ” shall mean the research activities in the Field commencing on the Effective Date to be conducted by the Parties pursuant to Section 3.1 of this Agreement

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

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and reflected in the Research Plan.

 

1.59.                      Sublicensee ” shall mean any Third Party to which Centocor grants a sublicense of the rights granted to Centocor pursuant to this Agreement.

 

1.60.                      Technology ” shall mean and include any and all unpatented proprietary ideas, inventions, trade secrets, discoveries, data, results, formulae, designs, specifications, methods, processes, formulations, techniques, know-how, technical information (including, without limitation, structural and functional information), process information, pre-clinical information, clinical information, and any and all Proprietary Materials, including all proprietary biological, chemical, pharmacological, toxicological, pre-clinical, clinical, assay, control and manufacturing data and materials.

 

1.61.                      Term ” shall mean the period commencing on the Effective Date and continuing until the expiration or termination of this Agreement in accordance with the terms hereof.

 

1.62.                      Territory ” shall mean all countries and jurisdictions of the world.

 

1.63.                      Third Party ” shall mean, as to a Party, any entity other than that Party and its respective Affiliates.

 

1.64.                      Third Party Payments ” shall have the meaning set forth in Section 5.3.2.

 

1.65.                      Upfront Fee ” shall have the meaning set forth in Section 5.1.1.

 

1.66.                      Valid Claim ” shall mean any claim within an issued, unexpired patent or pending patent application within the Licensed Patent Rights that (a) has not been finally cancelled, withdrawn, abandoned or rejected by any administrative agency or other body of competent jurisdiction, and (b) has not been revoked, held invalid, or declared unpatentable or unenforceable in a decision of a court or other body of competent jurisdiction that is unappealable or unappealed within the time allowed for appeal, and (c) has not been rendered unenforceable through disclaimer or otherwise, and (d) is not lost through an interference proceeding.

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

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2.                                       GRANT OF RIGHTS

 

2.1                                License Grants .

 

(a)                                    Commercialization License .

 

(i)                                      License to Centocor   Subject to the terms and conditions of this Agreement, ImmunoGen hereby grants to Centocor an exclusive, royalty-bearing license, including the right to grant sublicenses as described in Section 2.1(a)(ii) below, under the Licensed Patent Rights and Licensed Technology and ImmunoGen’s interest in Improvements, to Develop, have Developed, make, have made, use, have used, sell, have sold, offer for sale, import, have imported, export and have exported Licensed Products in the Field in the Territory.
 
(ii)                                   Right to Sublicense .  Centocor shall have the right freely to grant sublicenses to all or any portion of its rights under the license rights granted pursuant to Section 2.1(a)(i) hereof to any Third Party; provided , however , that (1) ImmunoGen shall be notified in writing of each such sublicense, (2) any and all sublicenses shall be consistent with the terms and conditions of this Agreement, and (3) Centocor shall remain obligated for the payment to ImmunoGen of all of its payment obligations hereunder, including, without limitation, the payment of any milestones and royalties described in Section 5 hereof.
 

(b)                                   Research Licenses .

 

(i)                                      Research License to Centocor   Subject to the terms and conditions of this Agreement, during the Term of this Agreement, ImmunoGen hereby grants to Centocor a fully paid-up, non-exclusive, royalty-free, worldwide license, without the right to grant sublicenses, under the Licensed Technology and Licensed Patent Rights and ImmunoGen’s interest in any Improvements, for the sole purpose of conducting the activities it is required to perform as part of the Research Program.
 
(ii)                                   Research License to ImmunoGen .  Subject to the terms and conditions of this Agreement, during the Term of this Agreement, Centocor hereby grants to ImmunoGen a fully paid-up, non-exclusive, royalty-free, worldwide license, without the right to grant sublicenses, under the Centocor Background Technology and Centocor Patent Rights and Centocor’s interest in any Improvements, Centocor Program Technology and Joint Program Technology, for the sole purpose of conducting the activities it is required to perform as part of the Research Program.

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

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2.2                                Retained Rights and Covenants .

 

(a)                                    Retained Rights .  Subject to the other terms of this Agreement (including, without limitation, Section 2.2(b)), ImmunoGen retains the right to use the Licensed Technology and its interest in any Improvements and practice the Licensed Patent Rights (a) to perform its obligations under this Agreement (including without limitation its obligation to manufacture Preclinical Materials and Clinical Materials in accordance with Section 4 of this Agreement) (b) to develop, have developed, make, have made, use, have used, sell, have sold, offer for sale, import, have imported, export and have exported any product that is not a Licensed Product, and (c) for any and all uses outside of the Field.

 

(b)                                   Covenants .  Notwithstanding anything to the contrary contained in Section 2.2(a) or 2.3 of this Agreement, ImmunoGen hereby agrees during the Term of this Agreement, that it shall not grant to any Third Party any license or other right under any Patent Rights or Technology Controlled by ImmunoGen to develop, have developed, commercialize, have commercialized, make or have made any product containing a conjugate of a MAY Compound to an Antibody which selectively and specifically binds with [**************************].

 

2.3                                Improvement License to ImmunoGen .  Centocor hereby grants to ImmunoGen a non-exclusive, fully paid, irrevocable, royalty-free license, including the right to grant sublicenses, under Centocor’s interest in Improvements Controlled by Centocor (a) to manufacture Clinical Materials or Preclinical Materials pursuant to the terms of this Agreement, and/or each applicable Supply Agreement (b) to develop, make, have made, use, sell, have sold, offer for sale, import, have imported, export and have exported any product that is not a Licensed Product, and (c) to otherwise exploit such Improvements for all uses outside of the Field.

 

3.                                       RESEARCH PROGRAM; DEVELOPMENT AND COMMERCIALIZATION
OF LICENSED PRODUCTS.

 

3.1                                Research Program .

 

(a)                                    Implementation of Research Program .  Promptly following the execution of this Agreement, the Parties shall cooperate in conducting the Research Program as described

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

15



 

in the Research Plan in Appendix 3.1 attached hereto. The Research Program shall be designed to facilitate the selection of the appropriate [************************] Antibodies and MAY Compounds to be used in preparing [*********************]-MAY Conjugates and the conduct of initial research with respect to the [*********************]-MAY Conjugates. The Research Program shall be conducted pursuant to a Research Budget agreed to by the Parties.  The Parties may, by mutual agreement, make adjustments in the Research Plan and Research Budget from time to time during the Term of this Agreement.  Each Party undertakes that the activities assigned to it in a Research Plan shall be conducted diligently and in good scientific manner in accordance with accepted laboratory practices and in compliance with any and all laws, regulations and bioethical conventions applicable to the jurisdiction in which those activities take place.

 

(b)                                   Collaborative Efforts and Reports .  The Parties agree that the successful execution of the Research Program will require the collaborative use of both Parties’ areas of expertise.  The Parties shall keep the Collaboration Committee and each other fully informed about the status of the Research Program.  Scientists at ImmunoGen and Centocor shall cooperate in the performance of the Research Program and, subject to any confidentiality obligations to Third Parties, shall exchange information and materials in a mutually acceptable secure manner as necessary to carry out the Research Program, but subject to the provisions of Section 6 hereof.  The Parties expect that such exchange of information and materials may involve short-term on-site visits by scientists of each Party to the facilities of the other Party.

 

(c)                                    Additional Obligations of ImmunoGen .  Subject to the other terms of this Agreement, ImmunoGen may, [******************************], conduct such additional research activities, as ImmunoGen, in its sole discretion, are necessary as useful for the Development of Licensed Products.  Without limiting the generality of the foregoing, ImmunoGen may from time to time, provide Centocor technical assistance within ImmunoGen’s area of expertise (or its subcontractors) concerning the Development of Licensed Products, provided that such technical assistance and expertise is within the scope of the Licensed Technology and/or Licensed Patent Rights covered under this Agreement.  Such technical

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

16



 

assistance and expertise shall include, but not be limited to, visits by ImmunoGen personnel to Centocor and visits by Centocor Personnel to ImmunoGen (or its subcontractors), at Centocor’s expense, at such times and for such periods of time as may be reasonably acceptable to the Parties.

 

(d)                                   Supply of Proprietary Materials .  From time to time during the Research Program Term, either Party (the “transferring Party”) may supply the other Party (the “recipient Party”) with its Proprietary Materials for use in the Research Program.  In connection therewith, the recipient Party hereby agrees that (i) it shall not use Proprietary Materials for any purpose other than exercising any rights granted to it or reserved by it hereunder; (ii) it shall use the Proprietary Materials only in compliance with all applicable, federal, state, and local laws and regulations; (iii) it shall not transfer any Proprietary Materials to any Third Party without the prior written consent of the transferring Party, except as expressly permitted hereby; (iv) the transferring Party shall retain full ownership of all such Proprietary Materials; and (v) upon the expiration or termination of this Agreement, the recipient Party shall at the instruction of the transferring Party either destroy or return any Proprietary Materials which are not the subject of the grant of a continuing license hereunder.

 

3.2                                Development and Commercialization .

 

(a)                                    Responsibility .  Subject to Section 3.3 of this Agreement, on and after the Effective Date, Centocor shall have sole control and authority over the Development and Commercialization of Licensed Products in the Field in the Territory, including, without limitation, (i) the conduct of all research and pre-clinical Development activities (including the assessment of alternative designs for the [**********************]-MAY Conjugates, the selection of the final [************************] Antibodies and MAY Compounds to be used in the [*********************]-MAY Conjugates and the selection of the [***********************]-MAY Conjugates to be Developed as Licensed Products, all preclinical and IND-enabling studies, including toxicology testing, any pharmaceutical development work on formulations or process development relating to any such Licensed Products), (ii) all activities related to human clinical trials, (iii) subject to Section 4 of this

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

17



 

Agreement, all activities relating to the manufacture and supply of [***********************] Antibodies, MAY Compounds and Licensed Products, to the extent such activities relate to the Development and Commercialization of Licensed Products (including all required process development and scale up work with respect thereto), (iv) all Commercialization activities relating to any Licensed Product, and (v) all activities relating to any regulatory filings, registrations, applications and Regulatory Approvals relating to any of the foregoing (including any INDs or foreign equivalents, any manufacturing facility validation and/or licensure, any Drug Approval Applications and any other Regulatory Approvals).  Except as described in the next sentence, Centocor shall own all Technology arising from any such activities under this Agreement, including, without limitation, all regulatory filings, registrations, applications and Regulatory Approvals relating to Licensed Products (including any INDs or foreign equivalents, any Drug Approval Applications and any other Regulatory Approvals), and all of the foregoing Technology and filings, registrations and applications shall be considered Confidential Information solely owned by Centocor.  Notwithstanding the foregoing, ImmunoGen shall own all Technology arising from ImmunoGen’s activities relating to the manufacture and supply of MAY Compounds to Centocor and all of the foregoing Technology shall be considered Confidential Information solely owned by ImmunoGen.  Notwithstanding anything to the contrary in this Agreement, (i) all activities relating to Development and Commercialization of Licensed Products under this Agreement shall be undertaken at Centocor’s sole cost and expense, except as otherwise expressly provided in this Agreement, (ii) all business decisions, including, but not limited to, the design, sale, price and promotion of Licensed Products under this Agreement and the decision whether to market any particular Licensed Product shall be within the sole discretion of Centocor, (iii) any marketing of a Licensed Product in one market or country shall not obligate Centocor to market said Licensed Product in any other market or country and (iv) Centocor makes no warranty or representation that the marketing of any Licensed Product shall be the exclusive means by which Centocor will participate in the Field to which the Licensed Product relates.

 

(b)                                   Due Diligence .  Centocor will use commercially reasonable efforts to

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

18



 

Develop and Commercialize Licensed Products, and to undertake investigations and actions required to obtain appropriate Regulatory Approvals necessary to market Licensed Products, in the Field and in the Territory, such commercially reasonable efforts to be in accordance with the efforts and resources Centocor would use for a compound owned by it or to which it has rights, which is of similar market potential at a similar stage in development as the applicable Licensed Product, taking into account the proprietary position of the Licensed Product, the relative potential safety and efficacy of the Licensed Product, the regulatory requirements involved in its Development, Commercialization and Regulatory Approval, the cost of goods and availability of capacity to manufacture and supply the Licensed Product at commercial scale, and other relevant factors including, without limitation, technical, legal, scientific or medical factors.  In determining whether Centocor is using the efforts described in this Section 4.4 to Develop a Licensed Product the Parties shall consider, among other things, whether such Licensed Product is in Active Development.  “Active Development” shall mean that at any given time Centocor shall be diligently engaging in one or more of the following Development activities for a given Licensed Product: [*************************************************************] from the [************************] or [****************************] for any [********************************************************] being [*******] or [***************] or [******************************************************* **************************************************************] and [*******************] or [********************] and [*****************] from a [**********************] and [********************] within [******************] to [********] any of the preceding activities.  Notwithstanding the foregoing, Centocor shall not be considered to have failed to meet its obligation to use such efforts or have a Licensed Product in Active Development if such failure is due to the failure on the part of ImmunoGen to provide Preclinical or Clinical Materials under Article 4 hereof.  In the event that Centocor fails to use commercially reasonable efforts as required hereunder, then, ImmunoGen’s sole remedy shall be the right, in its sole discretion to (i) terminate the licenses granted under Section 2.1 this Agreement for breach under Section 8.2(b) below (including the notice and cure provisions

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

19



 

therein) or (ii) convert the licenses granted under Section 2.1 of this Agreement from exclusive licenses to non-exclusive licenses, in either case only as such licenses apply to such Licensed Product in such country, which termination or conversion, as the case may be, shall be effective upon expiration of the cure period specified in 8.2(b) below provided that such failure remains uncured upon such expiration.

 

3.3                                Updates and Reports; Notification of Milestones; Exchange of Adverse Event Information .

 

(a)                                    Updates and Reports .  Centocor shall keep ImmunoGen informed of the progress of Centocor’s efforts to Develop and Commercialize Licensed Products in the Field in the Territory by providing ImmunoGen with brief written reports no less frequently than on each anniversary of the Effective Date during the Term of this Agreement (commencing with the first anniversary of the Effective Date) which shall summarize Centocor’s efforts to Develop and Commercialize such Licensed Products, identify the Drug Approval Applications that Centocor and its Sublicensees have filed, sought or obtained in the prior twelve (12)-month period, and any they reasonably expect to make, seek or attempt to obtain in the following twelve (12)-month period.  The Parties agree that the minutes of the Collaboration Committee meetings may serve as reports hereunder, to the extent such minutes adequately address the above issues.

 

(b)                                   Notification of Milestone Achievement .  Centocor shall provide ImmunoGen with prompt written notice of the occurrence of any event giving rise to an obligation to make a milestone payment to ImmunoGen under Section 5.1.2, which shall in any event be no later than [***********] days after the occurrence of such event, and shall provide ImmunoGen with prompt written notice of the occurrence of the First Commercial Sale of any Licensed Product.  In the event that, notwithstanding the fact that Centocor has not given any such notice, ImmunoGen believes any such milestone event has occurred, it shall so notify Centocor in writing, and shall provide to Centocor the data and information demonstrating that the conditions for payment have been achieved.  Within [***] ([***]) days of its receipt of such notice, the Parties shall meet to review the data and information and shall agree in good faith whether or not the conditions for payment have been achieved.

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

20



 

(c)                                    Adverse Events .  As the owner of all regulatory approvals, Centocor will be primarily responsible for Adverse Event, safety and pharmacovigilence reporting on all Licensed Products.  To the extent that it may apply to a Licensed Product, ImmunoGen agrees to provide Centocor with Adverse Event and product complaint information relating to any product containing any MAY Compound that is compiled and prepared by ImmunoGen or any Third Party in the normal course of business in connection with the development, commercialization or sale of any such product, in accordance with procedures that shall be agreed to by the Parties based, in general, on Schedule D attached hereto (it being the understanding of the Parties that such Schedule D is included as an example only and shall not be binding upon the Parties); provided , however , that the foregoing shall not require ImmunoGen to violate any agreements with or confidentiality obligations owed to any Third Party.  In addition, Centocor agrees to provide ImmunoGen with agreed upon Adverse Event information and product complaint information relating to Licensed Products as compiled and prepared by Centocor in the normal course of business in connection with the Development or Commercialization of any Licensed Product, within time frames consistent with reporting obligations under applicable laws and regulations in accordance with procedures that shall be agreed to by the Parties based, in general, on Schedule D attached hereto (it being the understanding of the Parties that such Schedule D is included as an example only and shall not be binding upon the Parties).  Centocor shall provide its Adverse Event and product complaint information hereunder to ImmunoGen’s designated representative, who shall be its Chief Regulatory Officer unless ImmunoGen otherwise notifies Centocor.  ImmunoGen shall provide its Adverse Event and product complaint information hereunder to Centocor’s designated representative identified on Schedule D unless Centocor otherwise notifies ImmunoGen.

 

(d)                                   Correspondence for Licensed Products.   To the extent reasonably practicable and subject to any Third Party confidentiality obligations, Centocor shall provide ImmunoGen with copies of any material documents or correspondence pertaining to ImmunoGen’s manufacture of Preclinical Materials, Clinical Materials or any Licensed Product and prepared for submission to the FDA and any material documents or other correspondence

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

21



 

received from the FDA pertaining to ImmunoGen’s manufacture of Preclinical Materials, Clinical Materials or any Licensed Product.  ImmunoGen shall complete its review within [********] days after receipt of the proposed submission. When requested in writing, ImmunoGen shall provide reasonable assistance to Centocor in obtaining Regulatory Approvals for Licensed Product.  Notwithstanding the foregoing, Centocor shall have the sole responsibility for, and ImmunoGen agrees that Centocor shall be the sole owner of, any Regulatory Approval for the Licensed Product.

 

(e)                                    Confidential Information .  All reports, updates, Adverse Event, product complaint and other information provided by the disclosing Party to the receiving Party under this Agreement (including under this Section 3.3), shall be considered Confidential Information of the disclosing Party, subject to the terms of Section 6.

 

3.4                                Collaboration Committee .

 

(a)                                    Mandate and Establishment of Committee .  Promptly after the Effective Date, the Parties shall form a Collaboration Committee to serve as a forum for coordination and communication between the Parties with respect to the Research Program and/or the development of manufacturing processes applicable to any MAY Compound or Licensed Product covered by this Agreement (including, without limitation, all process science and process development work, formulation work, and quality control/assurance work hereunder), and to assist Centocor in its exercise of its rights to make or have made Licensed Products under this Agreement.  Within thirty (30) days after the Effective Date, the Parties shall each nominate an equal number of representatives (which shall be no less than two (2) each) for membership on the Collaboration Committee.  Each Party may change its representative(s) as it deems appropriate by notice to the other Party.

 

(b)                                   Chair of Committee; Meetings .  The chair of the Collaboration Committee shall be one of the Centocor representatives on the Collaboration Committee, as designated by Centocor.  The Collaboration Committee shall meet on a semi-annual basis or other schedule agreed upon by the Parties, unless at least thirty (30) days in advance of any meeting the chair of the Collaboration Committee determines that there is no need for a meeting.  In such instance,

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

22



 

the next Collaboration Committee meeting shall also be scheduled as agreed upon by the Parties.  The location of meetings of the Collaboration Committee shall alternate between ImmunoGen’s offices and Centocor’s offices in Cambridge, Massachusetts and Malvern/Radnor/Horsham/ Chesterbrook/Springhouse, Pennsylvania, respectively, unless otherwise agreed by the Parties. As agreed upon by the Parties, Collaboration Committee meetings may be face-to-face or may be conducted through teleconferences and/or videoconferences.  In addition to its Collaboration Committee representatives, each Party shall be entitled to have other employees attend such meetings to present and participate, though not in a decision-making capacity.  Each Party shall bear its own costs and expenses, including travel and lodging expense, that may be incurred by Collaboration Committee representatives or other attendees at Collaboration Committee meetings, as a result of such meetings hereunder.  Minutes of each Collaboration Committee meeting will be transcribed and issued to members of the Collaboration Committee by the chair within thirty (30) days after each meeting, and such minutes shall be reviewed and modified as mutually required to obtain approval of such minutes promptly thereafter.

 

4.                                       SUPPLY AND MANUFACTURING OBLIGATIONS

 

4.1                                Supply of Preclinical Materials, Clinical Materials and Licensed Product .  Centocor shall be responsible, at its sole cost, for manufacturing or having manufactured through Third Party contract manufacturers, any materials (including without limitation, all [**********************] Antibodies, MAY Compounds and [******************]-MAY Conjugates) as may be required for all preclinical and clinical studies necessary to obtain Regulatory Approval of Licensed Products and any materials and/or quantities of each Licensed Product as may required for all preclinical and clinical studies applicable to such Licensed Product and for Commercialization of such Licensed Product.

 

4.2                                Supply of Preclinical Materials by ImmunoGen .  Notwithstanding anything to the contrary in Section 4.1, during the Term of this Agreement, Centocor may request ImmunoGen to supply Centocor with such quantities of Preclinical Materials as may be reasonably required by Centocor in order to conduct all pre-clinical Development activities

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

23



 

(including, without limitation, toxicology testing) relating to Licensed Products.  Centocor shall order all amounts of Preclinical Materials, and ImmunoGen shall deliver all such ordered amounts, in accordance with advance ordering timeframes and delivery timeframes and specifications to be agreed upon by the Parties.  To the extent Centocor requests ImmunoGen to manufacture any [*********************]-MAY Conjugate, Centocor shall supply ImmunoGen with quantities of [***************************] Antibodies sufficient to enable ImmunoGen to produce such [**************************]-MAY Conjugate.  ImmunoGen shall use commercially reasonable efforts to deliver to Centocor such amounts of Preclinical Materials as are ordered by Centocor in accordance with the foregoing (including such agreed upon timeframes) in a timely manner; provided , that , to the extent such Preclinical Materials are [************************]-MAY Conjugates, ImmunoGen’s obligations shall be contingent on ImmunoGen’s receipt of the required quantities of [************************] Antibodies from Centocor.  In connection with any ordering of Preclinical Materials by Centocor, ImmunoGen shall provide Centocor promptly with ImmunoGen’s good faith estimate of the Cost for manufacture and supply of such Preclinical Materials.  ImmunoGen’s price to supply Preclinical Materials to Centocor shall equal [*************************] for such Preclinical Materials.  In connection with such supply, Centocor hereby agrees that (a) it shall not use the Preclinical Materials in any human subject, (b) it shall use the Preclinical Materials in compliance with all applicable federal, state and local laws and regulations, and (c) it (as a matter of contract between itself and ImmunoGen) shall assume all liability for damages that may arise from the use, storage and disposal of any Preclinical Materials.  Centocor shall be entitled to transfer Preclinical Materials to any Third Party under terms obligating such Third Party not to transfer or use such Preclinical Materials except in compliance with the foregoing clauses (a) and (b) of this Section 4.2.

 

4.3                                Supply of Clinical Materials by ImmunoGen .  If, during the Term of this Agreement, Centocor requests in writing that ImmunoGen supply Centocor with such quantities of Clinical Materials as may be reasonably required by Centocor in order to conduct human clinical trials of such Clinical Materials through the completion of non-pivotal Phase II Clinical

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

24



 

Trials for such Clinical Materials, ImmunoGen will use commercially reasonable efforts to supply Centocor with such Clinical Materials.  If, during the Term of this Agreement, Centocor requests in writing that ImmunoGen supply it with Clinical Materials in connection with the conduct of Pivotal Clinical Trials, ImmunoGen will supply Centocor with such Clinical Materials only to the extent ImmunoGen has the capability to do so at the time of Centocor’s request.  In either event, the Parties shall share information concerning specifications, forecasting and capacity requirements in order to adequately plan for the manufacture of such Clinical Materials. To the extent Centocor requests ImmunoGen to manufacture Clinical Materials as provided in the foregoing sentences, ImmunoGen and Centocor shall enter into a separate supply and quality agreements detailing the terms of supply for any Clinical Materials that ImmunoGen is so requested to supply to Centocor for the purpose of conducting clinical trials, which supply agreement shall include, without limitation, the terms set forth on Schedule B attached hereto and the remainder of this Section 4.3 (the “Supply Agreement”).  Subject to the foregoing, Centocor shall order all amounts of Clinical Materials, and ImmunoGen shall deliver all such ordered amounts, in accordance with forecasting parameters, advance ordering timeframes and delivery timeframes to be agreed upon by the Parties in the Supply Agreement.  The Supply Agreement further shall provide that ImmunoGen shall use commercially reasonable efforts to deliver such amounts of Clinical Materials ordered in accordance with the foregoing (including such agreed upon timeframes) in a timely manner; provided , that , ImmunoGen’s obligations shall be contingent on ImmunoGen’s receipt of the required quantities of [************************] Antibodies from Centocor.  In connection with any ordering of Clinical Materials by Centocor, ImmunoGen shall provide Centocor promptly with ImmunoGen’s good faith estimate of the Cost for manufacture and supply of such Clinical Materials.  The Supply Agreement shall provide that ImmunoGen’s price to supply Clinical Materials to Centocor shall equal [************************************] for such Clinical Materials.  Centocor hereby agrees that (a) it shall use the Clinical Materials in compliance with all applicable federal, state and local laws, and (b) it (as a matter of contract between itself and ImmunoGen) shall assume all liability for damages that may arise from the

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

25



 

use, storage and disposal of such Clinical Materials.  Centocor shall be entitled to transfer Clinical Materials to any Third Party under terms obligating such Third Party not to transfer or use such Clinical Materials except in compliance with the foregoing clause (a) of this Section 4.3.

 

4.4                                Purchase of Dedicated Equipment .   If, during the Term of this Agreement, ImmunoGen determines in good faith that it is necessary or advisable to purchase Dedicated Equipment in order to perform any of its obligations to manufacture Preclinical Materials and Clinical Materials under Sections 4.2 or 4.3 of this Agreement, then ImmunoGen shall provide Centocor with written notice of such determination, along with the estimated price for such purchase and quality parameters for the Dedicated Equipment, for Centocor’s approval of such price and features.  Promptly after the consummation of such purchase, assuming that Centocor has provided its approval hereunder, ImmunoGen shall provide Centocor with a copy of the invoice or invoices reflecting such purchase, and Centocor shall reimburse ImmunoGen for the purchase of all such approved Dedicated Equipment hereunder within [****************] of its receipt of such invoice from ImmunoGen; provided , however , that no costs reimbursed by Centocor hereunder (or depreciation of such purchased equipment or instruments) shall be included within the calculation of any Costs under this Agreement.  Centocor shall have title and ownership of all such Dedicated Equipment purchased pursuant to this Section 4.4, and shall have the right to reclaim or retain possession of such Dedicated Equipment at its expense upon reasonable notice at such time as it is no longer required for use by ImmunoGen to carry out this Agreement.  Notwithstanding the foregoing, the purchase of items including, but not limited to, routine lab equipment, biological materials, products and reagents reasonably required by ImmunoGen to conduct the Research Program shall be included in the Research Budget and shall be ImmunoGen’s obligation and responsibility.

 

4.5                                Process Development Activities .  To the extent that Centocor requests that ImmunoGen manufacture Preclinical Materials or Clinical Materials as described in this Section 4, ImmunoGen shall conduct such process development activities as the Parties agree are necessary to produce the quantities of Preclinical Materials or Clinical Materials so ordered,

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

26



 

which process development activities shall be included within the calculation of Cost to be paid by Centocor pursuant to Sections 4.2 and/or 4.3 of this Agreement and/or the Supply Agreement.

 

4.6                                Audit Rights

 

4.6.1                      Audit of Records .  ImmunoGen will maintain complete and accurate records which are relevant to its supply of Preclinical Materials as described in this Section 4, for subsequent use in GLP toxicology studies, including records concerning the Costs, purchase of Dedicated Equipment and Process Development Activities.  ImmunoGen shall maintain all records relating thereto in good order.  At the request of Centocor, upon at least [***********] business days’ prior written notice, but no more often than once per year, and at its sole expense (except as otherwise provided herein), ImmunoGen shall permit an independent certified public accountant reasonably selected by Centocor and reasonably acceptable to ImmunoGen to inspect (during regular business hours) the relevant records required to be maintained by ImmunoGen under this Section 4.5 (including records pertaining to ImmunoGen’s compliance with the Policy described in Section 9.1).  At Centocor’s request, the accountant shall be entitled to audit the then-preceding [***********] years of ImmunoGen’s records for purposes of verifying ImmunoGen’s records concerning Costs and its purchase of Dedicated Equipment.  To the extent requested by ImmunoGen the accountant shall enter into a confidentiality agreement with both Parties substantially similar to the provisions of Section 6 limiting the disclosure and use of such information by such accountant to authorized representatives of the Parties and the purposes germane to this Section 4.5.  The results of any such audit shall be made available to both Parties and shall be binding on both Parties.  Centocor agrees to treat the results of any such accountant’s review of ImmunoGen’s records under this Section 4.5 as Confidential Information of ImmunoGen subject to the terms of Section 6.  If any such audit reveals an overcharge to Centocor attributable to a deficiency in the calculation of Costs, or the purchase of Dedicated Equipment, ImmunoGen shall promptly pay Centocor the amount of the overpayment (plus interest thereon at the rate provided in Section 5.7 above), and if such overpayment is by [****] percent [*******] or more, ImmunoGen shall pay the costs and expenses of the audit.

 

4.6.2                      Audit of Facility .  ImmunoGen agrees that, to the extent ImmunoGen

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

27



 

manufactures any Preclinical Materials under this Section 4 for subsequent use in GLP toxicology studies, Centocor shall have the right to audit, under appropriate confidentiality provisions, during normal business hours and not more often than once per year, the facilities employed and the documentation utilized by ImmunoGen or its contractors or subcontractors for manufacturing Preclinical Materials.  Centocor may appoint a Third Party reasonably acceptable to ImmunoGen to perform such audit; provided Centocor hereby warrants that such Third Party will abide by secrecy and non-use obligations no less stringent than those contained in this Agreement and, to the extent requested by ImmunoGen, Cenotocor to provide ImmunoGen with a copy of the confidentiality agreement evidencing such secrecy and non-use obligations.  All such audits shall be at Centocor’s sole cost and expense.  Centocor will notify ImmunoGen at least [************] business days in advance of such an audit by Centocor and [***********] business days in advance of such an audit by a Third Party.  ImmunoGen shall use commercially reasonable efforts to remedy any material deficiencies identified in such audit as soon as possible.  In the event that, subject to the obligation of ImmunoGen to use commercially re


 
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